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Accessibility of evidence-based behavioral health interventions is one of the main challenges in health care and effective treatment approaches are not always available for patients that would benefit from them. Digitization has dramatically changed the health care landscape. Although mHealth has shown promise in addressing issues of accessibility and reach, there is vast room for improvements. The integration of technical innovations and theory driven development is a key concern. Digital solutions developed by industry alone often lack a clear theoretical framework and the solutions are not properly evaluated to meet the standards of scientifically proven efficacy. On the other hand, mHealth interventions developed in academia may be theory driven but lack user friendliness and are commonly technically outdated by the time they are implemented in regular care, if they ever are. In an ongoing project aimed at scientific innovation, the mHealth Agile Development and Evaluation Lifecycle was used to combine strengths from both industry and academia in the development of ACTsmart – a smartphone-based Acceptance and Commitment Therapy treatment for adult chronic pain patients. The present study describes the early development of ACTsmart, in the process of moving the product from alpha testing to a clinical trial ready solution.
Learn More >This clinical trial evaluated the independent and combined effects of a tricyclic antidepressant (desipramine) and cognitive behavioral therapy (CBT) for chronic back pain relative to an active placebo treatment. Participants (n=142) were patients experiencing daily chronic back pain at an intensity of ≥4/10 who were randomized to a single center, double blind, 12-week, four-arm, parallel groups controlled clinical trial of: 1) low concentration desipramine titrated to reach a serum concentration level of 15-65 ng/ml; 2) CBT and active placebo medication (benzotropine mesylate, 0.125mg); 3) low concentration desipramine and CBT; and 4) active benztropine placebo medication. Participants completed the Differential Description Scale and Roland-Morris Disability Questionnaires pre and post-treatment as validated measures of outcomes in back pain intensity and disability, respectively. Participants within each condition showed significant reductions from pre to post-treatment in pain intensity (mean changes ranged from = -2.58-3.87, Cohen's d's = 0.46-0.84) and improvements in pain disability (mean changes = -3.04-4.29, Cohen's d's = 0.54-0.88). However, intent-to-treat analyses at post-treatment showed no significant differences between any condition, with small effect sizes ranging from .06-.27. The results from this clinical trial did not support the hypothesis that desipramine, CBT, or their combination would be statistically superior to an active medicine placebo for reducing chronic back pain intensity or disability. Key limitations included recruiting 71% of the planned sample size and use of multiple inclusion/exclusion criteria that may limit generalizability to broader populations of patients with chronic back pain.
Learn More >: Document headache presence, intensity, and interference after concussion(s), as well as examine its association with cognition.: Participants 8-19 years of age were assessed on average 34 months ( = 21.5) after an orthopedic injury (OI, = 29), single concussion ( = 21), or multiple concussions ( = 15).: Headache intensity was rated using the Headache Rating Scale and headache interference was rated using the Post-Concussion Symptom Inventory (PCSI). Cognition was rated using the PCSI and measured using CNS Vital Signs.: Type of injury did not differ significantly in headache presence or intensity. However, there was a dose-response relationship found for children's ratings of headache interference, which was rated highest among children with multiple concussions, intermediate among those with single concussion, and lowest among children with OI. Both headache intensity and interference ratings correlated significantly with self and parent ratings of cognition on the PCSI, but not with cognitive test performance.: Youth with single or multiple concussions report greater headache interference – but not higher headache intensity – compared to youth without concussion. Although higher headache intensity and interference were associated with more self-reported cognitive symptoms, headaches did not correlate with cognitive test performance.
Learn More >Our sensory impressions of pain are generally thought to represent the noxious properties of an agent but can be influenced by the predicted level of threat. Predictions can be sourced from higher-order cognitive processes such as schemas, but the extent to which schemas can influence pain perception relative to bottom-up sensory inputs and the underlying neural underpinnings of such phenomenon are unclear. Here we investigate how threat predictions generated from learning a cognitive schema leads to inaccurate sensory impressions of the pain stimulus. Healthy men and women participants first detected a linear association between cue-values and stimulus intensity and rated pain to reflect the linear schema when compared with un-cued heat stimuli. The effect of bias on pain ratings was reduced when prediction errors increased, but pain perception was only partially updated when measured against stepped increases in prediction errors. Cognitive, striatal, and sensory regions graded their responses to changes in predicted threat despite of the prediction errors (p<0.05, corrected). Individuals with more catastrophic thinking about pain and with low mindfulness were significantly more reliant on the schema than on the sensory evidence from the pain stimulus. These behavioral differences mapped to variability in responses of the striatum and ventral medial prefrontal cortex. Thus, this study demonstrates a significant role of higher-order schemas on pain perception and indicates that pain perception is biased more towards predictions and less towards nociceptive inputs in individuals who report less mindfulness and more fear of pain.Significance statement: This study demonstrates that threat predictions generated from cognitive schemas continue to influence pain perception despite of increasing prediction errors arising in pain pathways. Individuals first formed a cognitive schema of linearity in the relationship between the cued threat value and the stimulus intensity. Subsequently, the linearity was reduced gradually, and participants partially updated their evaluations of pain in relation with the stepped increases in prediction errors. Individuals who continued to rate pain based more on the predicted threat than on changes in nociceptive inputs reported high pain catastrophizing and less mindful-awareness scores. These two affects mapped to activity in the ventral and dorsal striatum respectively. These findings direct us to a significant role of top-down processes in pain perception.
Learn More >The aim of this Delphi survey was to establish an international consensus on the most useful outcome measures for research on the effectiveness of non-pharmacological interventions for migraine. This is important, since guidelines for pharmacological trials recommend measuring the frequency of headaches with 50% reduction considered a clinically meaningful effect. It is unclear whether the same recommendations apply to complementary (or adjunct) non-pharmacological approaches, whether the same cut-off levels need to be considered for effectiveness when used as an adjunct or stand-alone intervention, and what is meaningful to patients.
Learn More >There is substantial evidence that pain intensity and sleep are related, with findings generally suggesting more support for the influence of sleep on pain intensity than vice versa. However, the strength and direction of the relationship has been found to vary among different populations, with few studies in individuals with chronic physical disabilities.
Learn More >To evaluate the extent to which pain-related beliefs, appraisals, coping, and catastrophizing differ between countries, language groups, and country economy.
Learn More >Migraine and sleep disorders in children exhibit a bidirectional relationship. This relationship is based on shared pathophysiology. Migraine involves activation of the trigeminal vascular system. Nociceptive neurons that innervate the dura release various vasoactive peptides. Calcitonin gene-related peptide is the most active of these peptides. Neural pathways that are involved in sleep generation are divided into those responsible for circadian rhythm, wake promotion, non-rapid eye movement, and rapid eye movement sleep activation. Sleep state switches are a critical component of these systems. The cerebral structures, networks, and neurochemical systems that are involved in migraine align closely with those responsible for the regulation of sleep. Neurochemical systems that are involved with both the pathogenesis of migraine and regulation of sleep include adenosine, melatonin, orexin, and calcitonin gene-related peptide. Sleep disorders represent the most common comorbidity with migraine in childhood. The prevalence of parasomnias, obstructive sleep apnea, and sleep-related movement disorders is significantly greater in children migraineurs. Infantile colic is a precursor of childhood migraine. Treatment of comorbid sleep disorders is important for the appropriate management of children with migraine. Sleep-based behavioral interventions can be of substantial benefit. These interventions are particularly important in children due to limited evidence for effective migraine pharmacotherapy.
Learn More >Chronic non-cancer pain (CNCP) is a significant health burden among adults. Standard behavioral therapies typically focus on targeting negative affect (NA) and yield only modest treatment effects. The aims of this study were to systematically review and investigate the association between positive affect (PA) and pain severity among adults with CNCP. Databases search included MEDLINE (PubMed), PsycINFO, CINAHL, ProQuest Dissertations and Theses, OLASTER, Open Grey, and PsyArXiv (inception to July 23, 2019). We analyzed studies that: (1) employed observational, experimental, or intervention study designs; (2) enrolled individuals with CNCP (pain ≥ 12 weeks); and (3) reported full quantitative results on outcomes. Two researchers independently screened articles, extracted data, and assessed the risk of bias. The main meta-analysis was followed by subgroup analyses. All analyses were performed using random-effects models. Formal tests for heterogeneity (Q-statistic; I) and publication bias (p-curve and p-uniform*) were performed. We meta-analyzed 29 studies with 3521 participants. Results demonstrated that PA inversely impacts pain severity in people with CNCP (r = -0.23). Subgroup analyses showed a significant effect for gender and marginally significant effects for age in studies that adjusted for NA. On average, effect sizes for observational studies were larger in studies with a higher proportion of female respondents and in studies that did not adjust for NA. Finally, larger effect sizes were found in intervention studies with older compared with younger samples.
Learn More >Psychological characteristics are important in the development and progression of low back pain (LBP), however their role in persistent, severe LBP is unclear.
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